Clinical Research in Complementary and Integrative Medicine - 1st Edition - ISBN: 9780702034763, 9783437596520

Clinical Research in Complementary and Integrative Medicine

1st Edition

A Practical Training Book

Authors: Klaus Linde
eBook ISBN: 9783437596520
Paperback ISBN: 9780702034763
Imprint: Urban & Fischer
Published Date: 1st September 2011
Page Count: 208
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Description

Sie wollen eine Studie in durchführen und wissen nicht ganz genau, wie?
Kein Problem! Clinical Research zeigt Ihnen alle Aspekte verständlich und nachvollziehbar. Sie erhalten einem umfassenden Überblick und praxistaugliche Anleitungen.
Schritt für Schritt erarbeiten und üben Sie die Kriterien und - of course - all in english!
Dieses Buch hat mehr!
Mit dem Code im Buch haben Sie ab Aktivierung 12 Monate kostenlosen Online-Zugriff auf den Buchinhalt und die Abbildungen..
Angebot freibleibend

Kostenlos auf elsevier.de (http://www.elsevier.de)

Key Features

This practical training book:

  • systematically introduces the key aspects of study design and basic statistics.
  • helps you to develop, plan and execute your research project.
  • combines established theoretical approaches with practical skills applicable to your own clinical study.
  • is a step-by-step tutorial for a complete clinical study, which is illustrated in three case studies.
  • includes additional training exercises, featuring different study conditions and environments, that will help you to practice and test your knowledge.

Clinical Research in Complementary and Integrative Medicine – the best way to understand clinical research and to plan and perform your own study!

Free online access:

After activating the code inside this book you get free online access to the content and the illustrations for 12 months.

Table of Contents

Contents
1 Introduction   1
1.1 What do we mean by complementary medicine in this book?   1
1.2 The science behind clinical medicine   2
1.2.1 Major areas of research   2
1.2.2 Topics in clinical research   2
1.2.3 Evidence-based medicine   3
1.3 Why do we need research on complementary therapies?   3
1.4 Is research into complementary therapies special?   5
1.4.1 Why research into complementary therapies is somewhat different?   5
1.4.2 Strategic approaches to research into complementary medicine   6
1.4.3 Why it is difficult to realize strategic approaches?   6
1.5 Aims, target audience and structure of this book   7
I Theory – Things you should know before embarking on a clinical study   9
2 Basic study design   11
2.1 When is a treatment effective?   11
2.1.1 Why do we need control or comparison groups?   11
2.1.2 Types of controls and comparisons   12
2.1.3 Specific and non-specific effects   14
2.2 Bias – threats to internal validity   15
2.2.1 Prognostic and baseline differences between groups – why randomization is so desirable   15
2.2.2 Differences between groups after treatment has started – why blinding is so desirable   17
2.2.3 Attrition   17
2.2.4 Bias during analysis and reporting   18
2.3 Clinical studies and the real world – external validity   18
2.3.1 The need for balancing internal and external validity   18
2.3.2 Selection of study participants   20
2.3.3 Selection of study interventions   21
2.3.4 Selection of outcome measures   22
2.4 What study design for what purpose?   22
2.4.1 Studies without a control group   22
2.4.2 Studies with a non-randomized comparison group   25
2.4.3 Randomized trials   27
2.5 Establishing an evidence picture   31
3 Basic statistics   33
3.1 Why statistics?   33
3.2 Types of variables and their distribution   33
3.2.1 Categorical variables   33
3.2.2 Continuous variables   34
3.2.3 Categorical or continuous?   34
3.3 Summarizing your data   34
3.3.1 Calculating the mean and the median   35
3.3.2 The distribution of your data   35
3.3.3 Measuring variation within your study population   36
3.3.4 Measuring sampling variation   37
3.3.5 Standard deviation, standard error and confidence interval   38
3.4 Comparing two groups or two time points for one variable   38
3.4.1 Calculating summary measures for dichotomous variables   38
3.4.2 Calculating summary measures for continuous variables   39
3.4.3 Testing a hypothesis   40
3.4.4 Relevance of the p-value   41
Contents
3.4.5 Statistical tests for comparing means   42
3.4.6 Statistical tests for comparing proportions   42
3.4.7 Confidence intervals   42
3.4.8 Type I and type II errors   43
3.4.9 How to deal with multiple testing   43
3.5 Comparing more than two groups for one variable   44
3.5.1 Statistical models and tests for comparing more than two groups for one variable   44
3.6 Comparing two or more groups for more than one variable   45
3.6.1 Correcting for baseline differences   45
3.6.2 Logistic regression and statistical modelling   45
3.7 Analysis populations   46
3.8 Dealing with missing values   46
3.9 Interval hypotheses: equivalence/non-inferiority and superiority   47
II Practice – Planning, managing, analyzing and publishing a clinical study   49
4 Planning   51
4.1 Formulating the research question   51
4.1.1 Why a clear research question is so crucial   51
4.1.2 Practical steps   51
4.1.3 Case studies   54
4.2 Study Protocol   56
4.2.1 What is a study protocol?   56
4.2.2 Develop your study protocol – step by step   56
4.3 Interventions and Controls   59
4.3.1 Theoretical background   59
4.3.2 Define your control and interventions   62
4.3.3 Case studies   64
4.4 Randomization   65
4.4.1 Individual and cluster randomization   65
4.4.2 Practical steps   66
4.4.3 Case studies   70
4.5 What to do if you do not randomize   71
4.5.1 Taking baseline differences into account   72
4.5.2 Matching – practical steps   72
4.5.3 Adjusting analyses for imbalances – practical steps   73
4.5.4 Case study   74
4.6 Blinding   74
4.6.1 Should you go for blinding?   74
4.6.2 Practical steps   76
4.6.3 Case studies   79
4.7 Study participants   81
4.7.1 Who should be included in your study?   81
4.7.2 Practical steps   81
4.7.3 Case studies   83
4.8 Outcome measurement   85
4.8.1 Theoretical background   85
4.8.2 Define your outcome measures and prepare your CRF   89
4.8.3 Case studies on outcomes   91
4.9 Sample size calculation   93
4.9.1 What does sample size calculation mean?   93
4.9.2 Practical steps   94
4.9.3 Case studies   100
4.10 Ethics and regulatory aspects   102
4.10.1 Theoretical background on ethics   102
4.10.2 Getting approval from the IRB/Ethics Committee   103
4.10.3 Regulatory aspects   104
5 Study and data management   105
5.1 Project management   105
5.1.1 Phases of project management   105
5.1.2 Taking notes   105
5.2 Guidelines for clinical trials   106
5.3 Study management   107
5.3.1 Theoretical background   108
5.3.2 Manage your study   109
5.4 Data management   113
5.4.1 Theoretical background   113
5.4.2 Manage your data   116
5.5 Case studies   121
6 Data analysis   123
6.1 Analysing your own data step by step   123
6.1.1 Step 1: Define the analysis populations and the handling of missing values   123
6.1.2 Step 2: Identify the different types of variable   124
6.1.3 Step 3: Clarify what you can calculate from your data   124
6.1.4 Step 4: Choose suitable statistical methods   125
6.1.5 Step 5: Perform the statistical analysis   126
6.1.6 Step 6: Decide how you will present your results   127
6.1.7 Step 7: Interpret your results and draw your conclusions   127
6.2 Case studies   127
7 Publication   133
7.1 General issues   133
7.1.1 Why is publication so crucial?   133
7.1.2 Basic things to keep in mind   133
7.2 Early preparatory work   134
7.2.1 Define your aims   134
7.2.2 Deciding on authorship   134
7.2.3 Selecting a journal   135
7.2.4 Checking instructions for authors   137
7.2.5 Checking general guidelines for reporting   137
7.3 Writing the manuscript   137
7.3.1 Results section   138
7.3.2 Methods section   138
7.3.3 Introduction   139
7.3.4 Discussion   139
7.3.5 Abstract   140
7.3.6 References   140
7.3.7 Additional statements   140
7.3.8 Internal revision   141
7.4 Getting your manuscript accepted   141
7.4.1 Preparing the submission   141
7.4.2 Submitting the manuscript   142
7.4.3 What happens at the journal?   142
7.4.4 Revision   143
7.4.5 After rejection …   143
7.5 After acceptance   144
7.5.1 Proofreading   144
7.5.2 Finally: Publication   144
7.5.3 Dealing with mass media   144
III Putting a clinical study into context   145
8 Qualitative research   147
8.1 Research question and examples   147
8.2 Qualitative approaches   148
8.2.1 Ethnography   148
8.2.2 Field research   148
8.2.3 Case studies   149
8.3 Qualitative methods and types of data   149
8.3.1 Interviews   149
8.3.2 Observation   149
8.3.3 Written documents or pictures   150
8.4 Qualitative data analysis   150
8.4.1 Content analysis   150
8.4.2 Grounded theory   150
8.5 Quality assurance in qualitative research   151
8.6 Combining qualitative and quantitative research methods   151
9 Economic studies   153
9.1 Principles of economic analysis   153
9.1.1 Costing   153
9.1.2 Measuring the benefit   154
9.2 Types of economic evaluations   156
9.2.1 Cost of disease analysis   156
9.2.2 Cost-benefit analysis   157
9.2.3 Cost-effectiveness-analysis   157
9.2.4 Cost-utility analysis   157
9.2.5 Cost-minimization analysis   158
9.3 Examples of economic analysis   158
9.4 Critical appraisal   159
Contents
10 Single-case research   163
10.1 Why case reports are not scientific   163
10.2 Why single-case research is important?   163
10.3 Assessing causality in single cases   164
10.4 Experimental single-case studies   164
10.4.1 General aspects   164
10.4.2 Progressive approaches   165
10.4.3 Repetitive approaches   167
10.5 Observational single case studies   168
10.5.1 Retrospective case studies   168
10.5.2 Prospective case studies   168
10.5.3 Semi-prospective case studies   169
10.6 Cross-roads between research on single cases and groups of patients   169
10.6.1 Best case series   169
10.6.2 Multiple baseline studies   170
10.6.3 Single-case studies embedded in studies of groups of patients   170
10.6.4 Meta-analysis of single case studies   170
11 A brief look at other study designs   173
11.1 Cross-sectional studies/surveys   173
11.2 Diagnostic studies   175
11.3 Etiological and prognostic studies   177
 Appendix   181
 Index  187

Details

No. of pages:
208
Language:
English
Copyright:
© Urban & Fischer 2011
Published:
Imprint:
Urban & Fischer
eBook ISBN:
9783437596520
Paperback ISBN:
9780702034763

About the Author

Klaus Linde